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NCT01915498 · OUTCOME

Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events

Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation · Source last updated 2024-10-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the first dose of investigational product (IP) up to 28 days after the last dose, up to the data cutoff of date of 01 September 2017; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).

What was measured

A TEAE is any adverse event that began or worsened on or after the start of investigational product (IP) through 28 days after the last dose. A treatment-related TEAE is a TEAE that is suspected (possibly or probably related) by the Investigator to be related to the IP. A serious AE is one that at any dose of IP or at any time during the observation period met the following criteria: - Resulted in death; - Was life threatening; - Required inpatient hospitalization or prolongation of existing hospitalization; - Resulted in persistent or significant disability/incapacity; - Was a congenital anomaly/birth defect; - Was medically important. The intensity of each AE was graded from 1 to 5 according to the NCI CTCAE Version 4.03, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).

Analysis population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment

Groups in this outcome

Phase 2: Enasidenib 100 mg QD

Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 2: Enasidenib 100 mg QD105

Reported measurements

Any Treatment-emergent Adverse Event (TEAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD105Not reportedNot reportedNot reportedNot reported
TEAE Related to Investigational Product (IP)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD88Not reportedNot reportedNot reportedNot reported
Grade 3-4 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD92Not reportedNot reportedNot reportedNot reported
Grade 3-4 TEAE Related to IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD48Not reportedNot reportedNot reportedNot reported
Grade 5 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD30Not reportedNot reportedNot reportedNot reported
Grade 5 TEAE Related to IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD1Not reportedNot reportedNot reportedNot reported
Serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD85Not reportedNot reportedNot reportedNot reported
Serious TEAE Related to IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD34Not reportedNot reportedNot reportedNot reported
TEAE Leading to Discontinuation (D/C) of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD22Not reportedNot reportedNot reportedNot reported
TEAE Related to IP Leading to D/C of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD5Not reportedNot reportedNot reportedNot reported
TEAE Leading to Reduction of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD9Not reportedNot reportedNot reportedNot reported
TEAE Related to IP Leading to Reduction of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD7Not reportedNot reportedNot reportedNot reported
TEAE Leading to Interruption of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD49Not reportedNot reportedNot reportedNot reported
TEAE Related to IP Leading to Interruption of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        105
    title
    Any Treatment-emergent Adverse Event (TEAE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        88
    title
    TEAE Related to Investigational Product (IP)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        92
    title
    Grade 3-4 TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        48
    title
    Grade 3-4 TEAE Related to IP
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        30
    title
    Grade 5 TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 5 TEAE Related to IP
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        85
    title
    Serious TEAE
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        34
    title
    Serious TEAE Related to IP
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        22
    title
    TEAE Leading to Discontinuation (D/C) of IP
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    TEAE Related to IP Leading to D/C of IP
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    TEAE Leading to Reduction of IP
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    TEAE Related to IP Leading to Reduction of IP
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    units
    Participants
description
A TEAE is any adverse event that began or worsened on or after the start of investigational product (IP) through 28 days after the last dose. A treatment-related TEAE is a TEAE that is suspected (possibly or probably related) by the Investigator to be related to the IP. A serious AE is one that at any dose of IP or at any time during the observation period met the following criteria: - Resulted in death; - Was life threatening; - Required inpatient hospitalization or prolongation of existing hospitalization; - Resulted in persistent or significant disability/incapacity; - Was a congenital anomaly/birth defect; - Was medically important. The intensity of each AE was graded from 1 to 5 according to the NCI CTCAE Version 4.03, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).
groups
  1. description
    Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG000
    title
    Phase 2: Enasidenib 100 mg QD
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment
reporting Status
POSTED
time Frame
From the first dose of investigational product (IP) up to 28 days after the last dose, up to the data cutoff of date of 01 September 2017; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).
title
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice